NCL statement on FDA decision regarding CBD regulatory framework

January 27, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, applauds the FDA’s decision that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

NCL has been actively monitoring the growing threats to consumer safety as the market for untested, unapproved cannabidiol (CBD) products has exploded.

“This announcement is a critical step in the right direction. NCL supports FDA’s assessment that the existing dietary supplement and conventional food pathways are not appropriate for CBD,” said NCL Executive Director Sally Greenberg. “We are encouraged to see regulators prioritizing science and consumer safety, and we are committed to working with Congress, the FDA and other stakeholders to explore potential regulatory pathways that prioritize management of health risks associated with CBD and acceleration of rigorous research into cannabinoids’ therapeutic potential.”

“To that end, NCL was pleased to see FDA highlight the need for risk management tools, including clear labels, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”

Along with our partners – the Consumer Federation of America and the Community Anti-Drug Coalitions of America – NCL created the Consumers for Safe CBD in 2019, now Cannabis Consumer Watch, to educate consumers about the potential dangers of CBD in an unregulated market.

“We will continue advocating for policies that preserve meaningful, scientific research incentives while protecting public health,” Greenberg said. “As Congress works to develop a new regulatory pathway for CBD, it is critical that we bear in mind there’s greater urgency to address the risks posed by intoxicating cannabinoid products in the hemp market. As we’ve seen, these products pose significant risks to consumers, and must be addressed. Science should continue to guide policy discussions to ensure a safe and effective regulatory pathway.”

To learn more, visit cannabiswatch.org.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NCL welcomes FDA heightened concerns related to CBD products

December 29, 2022 [Updated]

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, is welcoming of the FDA’s heightened concern and attention to consumer safety risks in the CBD or cannabidiol consumer product market.

“The FDA’s continued engagement and work in the CBD consumer product market is critical to protecting consumer safety – the agency’s increased attention to CBD products is welcome news,” said Sally Greenberg, NCL’s Chief Executive Officer.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address this need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research.

Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD, which is why NCL is now shifting its focus to cannabis more broadly with the establishment of Cannabis Consumer Watch. Cannabidiol (CBD) is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

“NCL called on the FDA to develop regulations for the CBD marketplace. We also asked the CBD industry to ensure safety and promote a pathway for new products through clinically tested scientific research,” said Greenberg.

The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the CBD marketplace.

“Since 2019, NCL and other groups like the Consumer Federation of America and Community Anti-Drug Coalitions of America have been asking the FDA to step in and address the CBD marketplace – which is currently a ‘Wild West,’ with myriad unsubstantiated claims made by many in the industry about the so-called benefits of CBD products for everything from sleep disorders to cancer to pain relief, without regard to safe dosages,” Greenberg noted. “We want the agency to establish a regulatory framework for the legal sale of appropriate cannabis and cannabis-derived products. Some industry members have been asking for rules of the road as well. Any regulatory framework FDA recommends for cannabis-derived products must prioritize consumer safety and address the safety risks the agency has identified.”

There is only one FDA-approved drug on the market that employs CBD as its active ingredient – Epidiolex – a medication to treat a rare form of childhood epilepsy. That drug has undergone the rigorous FDA approval process and thus has substantiated therapeutic benefits that outweigh the risks which can be managed by prescribing physicians.

Cannabis Consumer Watch will continue to work to educate consumers about the potential dangers of CBD in an unregulated market and encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization.  Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.  For more information, visit https://nclnet.org.

NEW RESEARCH: CBD companies exploiting academic partnerships for marketing purposes

January 20, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The Journal of Studies on Alcohol and Drugs today released new research that reveals the various tactics cannabidiol (CBD) companies use to thwart the Food and Drug Administration (FDA) review process and assert that their therapeutical claims are backed by science.

The study, The Use of Academic Research in Medical-Cannabis Marketing: A Qualitative and Quantitative Review, illuminates the need for FDA regulatory approval and stronger oversight to address the risks to consumers and patients alike when companies exploit that system. The findings reveal nearly 1,000 health claims touting CBD’s ability to mitigate symptoms or treat mental health, autism, pain, sexual health, AIDS, cancer, COVID-19, and more, providing just a snapshot of the current, unregulated marketing tactics being used to mislead the public.

The research was commissioned by Consumers for Safe CBD, a campaign spearheaded by the National Consumers League and conducted by Data Science Solutions. The research took place in the summer of 2020 and was published today in the Journal.

“It’s important that consumers understand what they’re up against when it comes to the current marketplace,” said Sally Greenberg, Executive Director of the National Consumers League. “Day in and day out we see CBD products promoted by celebrities and ‘health experts’ who have no clue what is truly in the products they push. This research helps give a snapshot of just how many misleading claims are out there and will help consumers better understand how to identify — and know to question — marketing red flags.”

“Unfortunately, many CBD manufacturers talk quite a bit about research, but have rarely engaged in the kind of large-scale randomized controlled trials necessary to establish that a drug is safe and effective,” said Theo Caputi, M.P.H, M.SC. author of the study. “CBD products are flooding the retail marketplace — readily available to consumers — and this review shows a serious need for adequate research and testing to ensure safety of these products and effectiveness for the claims companies are making.”

Most of the top medical marijuana companies analyzed:

  • use the existence of academic partnerships and observational relationships in an effort to legitimize health claims, despite having little to no clinical trial activity;
  • routinely use academic research in marketing strategies (“research as marketing”) to mislead the public; and,
  • evade FDA approval process by creating their own pseudo-approval process, making products appear legitimate, safe, effective, and eligible for insurance coverage for a range of health claims through these “research as marketing” tactics.

“It is alarming to see so many companies purposefully evading the FDA process — the gold standard in consumer protection — and making therapeutic claims with little to no real, clinical evidence,” said Greenberg. “Many of these companies have received warning letters from the FDA, yet these harmful and misleading tactics continue. It’s time for Congress to empower FDA to use its full authority to protect consumers. Consumers for Safe CBD will continue to serve as a watchdog to ensure CBD products are safe and effective.”

The CBD market continues to grow despite the FDA stating that CBD cannot be generally regarded as safe (GRAS) for use in food and beverage products. According to a Statista report, CBD sales in the U.S. reached $4.6 billion in 2020. By 2026, the market is expected to grow to $16 billion. Consumers, through these “research as marketing” tactics, have been led to believe that CBD has both medical benefits and health maintenance effects. However, there is only thorough, scientific-backed proof of medical benefits in the one and only FDA-approved CBD prescription drug product available.

“It is arguably unethical and certainly misleading for commercial entities to use the legitimacy of early scientific research — and the announcement of such endeavors — as a marketing tool,” Caputi added, “In fact, this ‘research’ used — or even simply announced in press releases — is not nearly substantial enough to ensure safety and effectiveness of these products for therapeutic use. We must rely on the rigorous FDA approval process to be sure these products meet the gold standard for safety and efficacy.”

Click HERE to read the full study in the Journal of Studies on Alcohol and Drugs.

To  learn more about the risks of unregulated CBD, visit 4safecbd.org.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

What’s in that gummy bear could be hazardous to your kid’s health

CBD-infused foods and candies are often packaged and marketed to appeal to children, but buyer beware – there are a number of harmful ingredients that could be in a seemingly harmless gummy bear. Parents, teachers, guardians, and loved ones should know that none of the non-prescription CBD products on the market today – and the false medical claims often used to market these to consumers – have been tested or approved by the FDA.

NCL concerned as Senate bill puts consumers at risk from unregulated CBD

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—On May 19, Senators introduced the Hemp Access and Consumer Safety Act (S. 1698) which directs the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary ingredients or supplements. The National Consumers League (NCL) has long been concerned about the risks posed to consumers by unapproved cannabis-derived products. There is little research on the health and safety of CBD products, and as such the NCL does not support any legislation that would bypass the FDA’s regulatory authority and rigorous scientific review.

Currently, manufacturers and distributors of products containing CBD can petition the FDA for review and approval of a new ingredient as a dietary supplement (21 U.S.C. 350b). This approval process requires manufacturers and distributors to submit scientific data showing that the product is generally regarded as safe (GRAS). “Not only is there insufficient data to designate CBD products as GRAS, the FDA needs further data to determine safe dosage and concentration levels in order to set manufacturing and labeling requirements that ensure consumer safety,” said Jeanette Contreras, NCL Director of Health Policy.

As demonstrated in a white paper published by NCL, companies selling CBD products often focus their research efforts on weak and inexpensive studies, and then use the results for marketing purposes. “Current studies have not enhanced our scientific understanding of CBD, and policymakers should focus on incentivizing further clinical studies to bring new proven medical treatments to patients,” said Contreras. By mandating the FDA to regulate CBD as a dietary ingredient, S. 1698 would only further incentivize CBD manufacturers to forego rigorous clinical trials and the development of FDA-approved medicines. Easier approval as a dietary supplement will disincentivize real scientific research into any potential health benefits or risks of CBD products.

Under S. 1698, CBD manufacturers that make unwarranted claims of treating medical issues will seek expedited approval for their products as dietary supplements, rather than as drugs. We should be encouraging the development of new cannabis-derived medicines that have gone through the rigorous processes of randomized controlled trials and FDA approval. Considering the lack of existing research on CBD, this bill classifying CBD products as dietary supplements would irresponsibly lead to increased consumption of these products and limit the future development of cannabis-derived FDA approved treatments—while putting consumers at risk.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Consumer groups back FDA on NDI draft guidance

For immediate release: February 3, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—While the Biden Administration reviews late-hour regulations enacted by the Trump Administration, one important FDA guidance related to CBD deserves further consideration. The U.S. Food and Drug Administration recently withdrew its pending CBD guidance, which the agency had submitted last summer. These highly anticipated guidelines were meant to elaborate on FDA’s CBD enforcement policy as unregulated, untested CBD products continue to infiltrate the consumer market. The FDA has not yet shared a timeline for re-submitting the CBD guidance.

NCL launched Consumers for Safe CBD in 2019 to encourage the FDA to use its existing authority to curtail the proliferation of potentially dangerous, unapproved CBD products and to incentivize CBD research, clinical trials, and the creation of science-based CBD medicines.

NCL Executive Director Sally Greenberg released the following statement in response to the FDA pulling its guidance:

The early weeks of 2021 have brought about many changes – with a new Administration, a new Congress, and continued progress in the fight against COVID-19,  there is hope for a safer, healthier future. NCL will continue to do its part to protect consumers and promote public health.

Unfortunately, CBD manufacturers continue to make unsubstantiated medical claims about their products, putting consumers at risk. We remain hopeful that the FDA and the Biden Administration will join us in our efforts to protect consumers from the potential dangers that exist in the current unregulated, wild west CBD marketplace.

NCL urges the FDA to re-circulate an updated proposal that encourages further research into CBD and the development of science-based CBD medicines and uses the FDA’s authority to regulate the CBD marketplace to protect consumers from CBD products that may put them at risk. Consumers deserve a safer, healthier future. We simply cannot abandon this work now.

To learn more about NCL’s Consumers for Safe CBD campaign, click here. To learn more about FDA’s recent efforts related to CBD, click here.

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.

NCL concerned Congress seeks to approve unreviewed CDB products

Sept. 17, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—On September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.

Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.

In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.

NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Consumers for Safe CBD is working to protect, educate Americans

As America’s premier consumer advocacy organization, with a rich history of fighting to make the marketplace fair, safe, and healthy for consumers, NCL is hard at work on the most important issues in food and drug safety and to collaborate on improving consumer education.

In recent years, NCL has been observing the CBD, or cannabidiol, marketplace exploding, with products lining shelves of grocery stores, specialty shops—even gas stations. Products were appearing to make many claims or hint at miracle cures, and most consumers had no idea how or whether the products were being regulated. Who is making sure these tinctures, oils, gummies, and lotions are safe, and do they do what they claim?

This is why last year, NCL joined forces with the Consumer Federation of America and the Community Anti-Drug Coalitions of America, to create a national campaign called Consumers for Safe CBD.

NCL had identified a serious need for greater education among consumers about CBD, and that’s why Consumers for Safe CBD was created. Consumers for Safe CBD aims to help educate the public about the risks related to untested, unapproved CBD products on the market, champion the rights of consumers, and call on the U.S. Food and Drug Administration (FDA) and industry to do better to ensure safety and promote a pathway for new products through clinically tested scientific research.

“Cannabidiol, commonly referred to as CBD, is being used in a growing number of consumer products and is illegally sold in stores and on the Internet,” said NCL Executive Director Sally Greenberg. “We’re working to educate consumers and ensure accurate labeling, clear guidelines, and further research to protect against unknown and known risks of CBD products.”

NCL and its partners continue to raise awareness among consumers, policymakers, and regulators about the health risks associated with the unregulated CBD marketplace, in particular with the unproven health claims and often inaccurate labeling of products on the market today. Beyond the known health risks associated with unregulated CBD, there are a number of unscrupulous marketing tactics that prey on unsuspecting consumers. This includes false and dangerous claims that CBD has medical benefits that can prevent and stop the spread of the COVID-19.

By warning consumers about these false claims, participating in media interviews and publishing op-eds across the country, highlighting important research and reports, and sending letters to several retailers, state Attorneys General and Members of Congress, the campaign is working to protect consumers across the country from unapproved and potentially dangerous CBD products.

“We need to better understand the potential health benefits of CBD, but this can only be accomplished through clinical testing and scientifically validated methodologies,” said Greenberg. “We need the FDA to step up for consumers and for the public health.”

The time for action is now. CLICK HERE for more information about the Consumers for Safe CBD effort.

Sorting through bogus health claims

Across the United States, people are rising to the historic health needs and challenges posed by coronavirus, with healthcare workers on the frontlines risking their lives, and businesses pivoting to manufacture much-needed medical and protective supplies.

But deep concerns about the health implications—what happens to people who contract the disease from a health and financial perspective—are top of mind for many of us. And a cynical minority has seized on the crisis to employ unscrupulous, and frankly dangerous, marketing tactics to promote bogus products claiming to protect users against the coronavirus or provide relief for those infected—as well as peddling downright phony coronavirus testing products.

“These false claims touting unproven medical benefits are nothing more than craven attempts to take advantage of fearful consumers,” said NCL Executive Director Sally Greenberg.

“Moreover, they spread misinformation among consumers anxiously seeking ways to stay safe and healthy amidst the coronavirus crisis.”

In an op-ed in The Hill published in May, Greenberg noted that a number of CBD manufacturers and stores are falsely promoting unproven medical benefits of CBD products.

A CBD store in Portland, OR, for example, was recently ordered by the office of the state’s attorney general to take down signs claiming that its products could boost immunity against COVID-19.

“False claims such as this are particularly dangerous as consumers anxiously attempt to stay safe and healthy amidst the coronavirus crisis,” said Greenberg. “The need for science-backed treatments is significant and we must ensure products are tested and regulated for safety.”

Contrary to claims being made by CBD marketers that products containing cannabidiol can help those suffering from coronavirus, recent studies have actually found potential harmful side effects of cannabis products on infected coronavirus patients. Aurelius Data cautions the public against the potential harmful side effects that can come from consuming cannabis products with Tetrahydrocannabinol (THC) if a patient is infected with COVID-19. And studies have shown that many unregulated CBD products have been found to contain THC, though the labels may not disclose this.

“In these uncertain times, we urge consumers to continue to take precautions,” said Greenberg. “We urge everyone to follow CDC guidelines for COVID-19, practice safe social distancing, and at the same time avoid THC products and all untested, unregulated CBD products to help keep your family, friends, and communities safe.”